Particles in Parenterals PLUS Container/-Closure-Integrity Testing Conference

Particles in Parenterals PLUS Container/-Closure-Integrity Testing Conference

Barcelona, Spain

Seminar Nr. 15267


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Dr Martin Becker, Siegfried Hameln

Martin Dearden, PaxVax Berna

Dr Helmut Gaus, Boehringer Ingelheim

Al Goodwin, Amgen

Dr Dana Guazzo, USP

Dr Stephen Langille, FDA

Sunao Murai, Chugai Pharmaceutical

Dr Tobias Posset, Roche

Dr Heino Prinz, Rommelag AG

Dr Bernd Renger, Immediate Past Chair of the European QP Association

Dr Christoph Stark, Novartis

Marcel Uijlen, MSD


The Participants of the Particles in Parenterals Conference receive the current version of ECA’s Best Practice Paper on “Visual Inspection” for free!


Container/-Closure-Integrity Testing Conference

Container Closure Integrity testing of sterile drug products – requirements, expectations and exaggerations
  • Container Closure Integrity during Development, Qualification and Stability Testing
  • Regulatory, Pharmacopoeial and GMP requirements
  • System integrity versus container damages
  • Patient risks – do we need batch by batch testing?
  • Industrial best practice
Key Concepts in the Revised USP Guidance Chapter <1207> Package Integrity Evaluation – Sterile Chapter scope
New CCI terms and concepts:
  • Maximum allowable leakage limit
  • Inherent Package Integrity
  • Package Integrity Profile
  • CCI test method selection and validation guidance
Overview of container/closure integrity testing technologies
The presentation gives a comprehensive overview about current CCI technologies and techniques. It focuses in the first part on physical fundamentals of the different testing methods
  • Pressure / Vacuum Decay
  • LFC (Liquid Filled Container) leak testing
  • TDLAS/ HSA (frequency modulated spectroscopy)
  • High Voltage leak testing
  • 3µm IR and Mass-Spectroscopy
  • Force Detection
In the second part criteria or a selection matrix for test methods related to the product requirements and properties including primary container type, product properties (liquid, lyo, etc.) is presented. The main topics here are as follows.
  • In-line versus sample testing
  • Limits and false acceptance traps
  • Leak sizes and leak rates (false friends and measurable properties?)
Integrity testing of prefilled syringes
  • Sampling plan
  • He-leak testing
  • Limitations of the He-leakage test
  • Cross Validation with mCCI
100 % in-line CCI testing of ampoules
  • High Voltage inline testing: method description
  • Integration in the production process
  • Limits of the system
  • Qualification of the system
  • Validation
  • Routine Operation
100 % in-line testing of vials
  • System setup
  • Validation
  • Routine operation

Particles in Parenterals Conference

Regulatory Requirements for the visual inspection of parenterals
  • Compendial Requirements
  • 100 % visual inspection & AQL testing
  • PharmEur, USP, JP - similarities and differences
  • GMP Expectations
  • Manual inspection
  • Automated Inspection
  • Risk Management Considerations
FDA’s current thinking on particles and testing of parenterals
  • A summary of recent recall data due to visible particulates
  • The FDA’s take on AQL testing
  • Training and qualification of visual inspection staff
  • Automated inspection validation
  • A life-cycle approach to visible particle inspection and control
Presentation and discussion of the ECA Best Practice Paper on Visual Inspection
The best practice paper has been originally developed by the advisory board of the ECA Visual Inspection Group. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues. The first version of this paper has been published in September 2014 in Copenhagen. It has gained a broad acceptance in the industry afterwards. The current version as well as planned updates will be explained and discussed in Barcelona

Re-inspection of defect fractions - statistical evaluation
  • Mathematical description of inspection processes
  • Strategies for reinspection of defect fractions
  • Acceptance criteria for reinspection of defect fractions
  • Statistical evaluation
  • Design of the reinspection processes
Particle Testing and the interaction of production and QA
  • Monitoring and Trending
  • Improvements
  • Release process
Case Study MSD: Qualification/Validation of an automated system and routine operation
  • Training/Development test set
  • Qualification test set
  • Daily set up test set for automated system
  • Creating defects
  • Process Control Limits
In-line automated visual particle inspection of "Blow Fill Seal" containers for injectable drug products
A case study for line integration and validation in combination with related threshold studies
In this presentation a new 100% particle inspection machine at full production speed is presented along with real time case studies for line integration and threshold studies of current pharmaceutical products. It highlights also the benefits of this inspection process in relation to sensitive products like proteins or highly foaming liquids, which usually are disliked by machine vision inspection. Also a validation approach using threshold studies from human inspections based on a Knapp test approach as well as the related pseudo Knapp test results are presented.
Reduction and identification of particles
  • Handling of the particle load within the production area
  • Projects to reduce visible particles
  • Analytics and identification of visible particles
  • Example: particles on stoppers - analytic-limits and requirements
Case Study Amgen: How to set up in-line and desktop AVI systems
Summary of in-line AVI systems with focus on detection capability
Desktop AVI systems and where they can be used
Qualification of a desktop AVI system
One future roadmap for Automatic Visual Inspection
Quality requirements for injections shipped to the Japanese market
  • Japanese sensitivity for qualities of general and pharmaceutical products
  • General requirements for cosmetic qualities by Japanese medical agencies
  • Requirements for direct container suppliers by Japanese pharmaceutical companies
  • Requirements for qualities and production/inspection control by Japanese pharmaceutical companies/authorities/pharmacopeia
  • Control of packaging materials: Visual inspection of glass containers
    • Avoiding particles and other defects during glass manufacture
    • IPCs and final quality tests the suppler site
    • Vision Systems, machine setup and specifications


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